{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2020-10271", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200403", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20200303", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "408", "date_added": "20200403", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20190301", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "387029", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200403", "brand_name": "DA VINCI", "generic_name": "HARMONIC ACE", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "480275-08", "catalog_number": "480275", "lot_number": "M10190310", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200410", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874112738", "udi_public": "(01)10886874112738(17)210228(10)M10190310", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Fragmentation", "Material Fragmentation" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/11/2020;03/06/2020", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20250819", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20200403", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200306", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "9922449", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200306", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "186731524", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "67 - INTUITIVE SURGICAL, INC. (ISI) HAS NOT YET RECEIVED THE HARMONIC ACE INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. A LOG REVIEW WAS PERFORMED FOR THE HARMONIC ACE INSTRUMENT REPORTED IN THIS COMPLAINT ((B)(4)). AND THE FOLLOWING WAS FOUND: THE INSTRUMENT WAS LAST USED ON 03/03/2020. NO ERROR WOULD APPEAR IN THE LOGS FOR A FRAGMENT FALLING ISSUE. A SITE REVIEW WAS CONDUCTED AND NO OTHER COMPLAINTS WERE REPORTED FOR THIS INSTRUMENT. THERE WAS NO PHOTO OR VIDEO OF THE EVENT AVAILABLE FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT A FRAGMENT FELL INSIDE THE PATIENT WITH NO EVIDENCE OR CLAIM OF USER MISHANDLING/MISUSE. ALTHOUGH THE FRAGMENT WAS RETRIEVED AND NO PATIENT HARM OCCURRED, IF THIS MALFUNCTION WERE TO RECUR IT COULD POTENTIALLY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN OR UNAVAILABLE. THE EXPIRATION DATE FOR SECTION IS NOT APPLICABLE. FIELD IS NOT APPLICABLE BECAUSE THE PRODUCT IS NOT IMPLANTABLE. THE FIELDS ARE NOT AVAILABLE. FIELD IS NOT AVAILABLE." }, { "mdr_text_key": "186731525", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION PROCEDURE, WHILE USING THE HARMONIC ACE INSTRUMENT THE JAW BROKE OFF AND FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED AND REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS RETRIEVED USING A LAPAORSCOPIC GRASPER. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. ACCORDING TO THE CUSTOMER, IT WAS NOT NECESSARY TO PERFORM POST-OPERATIVE TESTS. THE FRAGMENT FELL WHILE DISSECTING FAT TISSUE (PERIHEPATIC). THE SURGEON DID NOT NOTICE ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT UNTIL THE SMALL PART FELL. THE CUSTOMER BELIEVED THAT SOMETHING RELATED WITH ULTRASONIC MOVEMENTS CAUSED THE INSTRUMENT TO BREAK. THE INSTRUMENT WAS USED FOR 20 MINUTES PRIOR TO THE ISSUE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THERE WAS NO DAMAGE OR COLLISION BETWEEN INSTRUMENTS OR HARD MATERIAL." }, { "mdr_text_key": "336070455", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "336070456", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON A RE-EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT HAS BEEN RECLASSIFIED AS AN ADVERSE EVENT AND PRODUCT PROBLEM RATHER THAN JUST A PRODUCT PROBLEM, AS PREVIOUSLY REPORTED." }, { "mdr_text_key": "316511066", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "61- INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND WITH A TEFLON PAD MISSING OFF ITS SLOT. THE CUSTOMER RETURNED ONE BIG PIECE OF TEFLON PAD WITH THE INSTRUMENT. THE TEFLON MATERIAL WAS PIECED BACK ONTO THE CLAMP ARM ASSEMBLY AND IT WAS DETERMINED THAT NOT ALL THE TEFLON PAD WAS RETURNED. A MISSING PIECE MEASURING APPROXIMATELY 0.07¿ X 0.04¿ WAS NOT RETURNED. HEAVY BIO DEBRIS AND CHAR MARKS RESIDED WITHIN THE CLAMP ARM. THE KNOWN COMMON CAUSE OF THIS FAILURE IS MISHANDLING/MISUSE. A REVIEW OF THE INSTRUMENT LOG FOR THE HARMONIC ACE INSTRUMENT ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2020 ON SYSTEM (B)(6). THIS IS A SINGLE USE INSTRUMENT AND THEREFORE WAS ON ITS FIRST AND FINAL USE. BASED ON THE INFORMATION OBTAINED FROM FAILURE ANALYSIS INVESTIGATIONS, THIS COMPLAINT IS BEING RECLASSIFIED AS A NON-REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE REPORTED FAILURE WAS FOUND TO BE DUE TO USER MISHANDLING/MISUSE. THERE IS NO EVIDENCE THAT THE ISI DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT OR THAT THE ISI DEVICE MALFUNCTIONED IN A WAY THAT COULD CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED." }, { "mdr_text_key": "316511067", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/06/2020;05/24/2023" } ] }